MESO

Quarterly Activity ReportNEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L

RBC Capital analyst Kennen MacKay initiates coverage on Mesoblast (NASDAQ:MESO) with a Sector Perform rating and announces Price Target of $12.

NEW YORK, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohn’s disease and ulcerative colitis has commenced at Cleveland Clinic.   Mesoblast Chief Medical Officer Dr Fred Grossman said: “Inflammation of the gut in Crohn’s disease and ulcerative colitis closely resembles the most severe manifestation of advanced-stage, life-threatening acute graft versus host disease (aGVHD). Mesoblast’s objective is to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to steroid-refractory aGVHD.”Mesenchymal stem cells (MSCs) promote healing of inflamed gut tissue by downregulating gut mucosal effector T-cell activity and promoting regulatory T-cell formation.1 MSCs have been tested in clinical trials of Crohn’s disease using two different modalities: intravenous infusions of MSCs to treat the primary inflammation of Crohn’s disease and local injections of MSCs to treat fistulae complicating Crohn’s disease.A third modality, endoscopic delivery of MSCs, has been successful in preclinical experimental models of colitis, reducing the excessive cytokine storm in the inflamed gut and resulting in tissue healing.2-3 The study at Cleveland Clinic will be the first in humans using local delivery of MSCs in the gut, and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohn’s disease where remestemcel-L was administered intravenously.The study’s lead investigator Dr Amy L. Lightner, Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic, stated: “We are aiming to establish a new treatment paradigm by administering remestemcel-L at one of two escalating doses, or placebo, directly to inflamed gut tissue in patients with medically refractory Crohn’s disease and ulcerative colitis, both highly debilitating conditions with significant, unmet medical needs.”According to recent estimates, more than three million people (1.3%) in the US alone have inflammatory bowel disease, with more than 33,000 new cases of Crohn’s disease and 38,000 new cases of ulcerative colitis diagnosed every year.4-6 Despite recent advances, approximately 30% of patients are primarily unresponsive to anti-TNFα agents and even among responders, up to 10% will lose their response to the drug every year. Up to 80% of patients with medically-refractory Crohn’s disease eventually require surgical treatment of their disease,7 which can have a devastating impact on quality of life.References 1.Mayne C and Williams C. Induced and natural regulatory T cells in the development of inflammatory bowel disease. Inflamm Bowel Dis 2013; 19: 1772–1788. 2.Molendijk I et al.  Intraluminal Injection of Mesenchymal Stromal Cells in Spheroids Attenuates Experimental Colitis. Journal of Crohn's and Colitis, 2016, 953–964 3.Pak S eta al.  Endoscopic Transplantation of Mesenchymal Stem Cell Sheets in Experimental Colitis in Rats. Scientific Reports | (2018) 8:11314 | DOI:10.1038/s41598-018-29617 4.CDC Facts and Figures 2015 5.Globaldata Pharmapoint 2018 6.Dahlhamer JM, MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169. 7.Crohn’s and Colitis FoundationAbout Remestemcel-L Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. Remestemcel-L is thought to have immunomodulatory properties to counteract severe inflammatory processes by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @MesoblastForward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. The risks, uncertainties and other factors that may impact our forward-looking statements include, but are not limited to: statements about the initiation, timing, progress and results of Mesoblast and its collaborators’ clinical studies; Mesoblast and its collaborators’ ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblast’s product candidates, if approved; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. Unless required by law, we do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.Release authorized by the Chief Executive.For further information, please contact:Media Julie Meldrum T: +61 3 9639 6036 E:julie.meldrum@mesoblast.com   Kristen Bothwell T: +1 917 613 5434 E:kbothwell@rubenstein.com     Investors Schond Greenway T: +212 880 2060 E: schond.greenway@mesoblast.com Paul Hughes    T: +61 3 9639 6036 E: paul.hughes@mesoblast.com

Dr. Rahman’s 18 years of pharmaceutical industry experience is highlighted by 16 successful BLA/NDAs and sBLAsVANCOUVER, Washington, Oct. 21, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the appointment of Mahboob U. Rahman, M.D., Ph.D., FACR, to the executive position of Chief Scientific Officer. Dr. Rahman was most recently Global Head of Immunology Development and Pharmacovigilance at Mesoblast Inc. (ASX: MSB; Nasdaq: MESO), a global leader in allogenic cellular medicines for inflammatory diseases.Dr. Rahman received his medical degree from Dhaka Medical College, Bangladesh and a Ph.D. in molecular biology from the Medical College of Pennsylvania. He completed his internal medicine residency at the Medical College of Pennsylvania, Philadelphia and rheumatology fellowship at Massachusetts General Hospital/Harvard Medical School, Boston. He then joined the Harvard Medical School faculty, and obtained an NIH Research Grant. His research interests included molecular mechanisms of joint destruction in inflammatory arthritides, as well as clinical research in various rheumatologic conditions. In early 2002, Dr. Rahman joined Centocor/Johnson & Johnson and was involved in the development of Infliximab, golimumab, ustekinumab and several small molecules as the Rheumatology Clinical Team Leader. In 2010, Dr. Rahman moved to Pfizer as a Vice President and the Therapeutic Area Head for Inflammatory Diseases and was involved in the development of tofacitiniband etanercept. In 2013, he joined Novartis as a Vice President and the Therapeutic Area Head for Immunology and Musculoskeletal Disease, where he was involved in the development of several compounds of which two achieved FDA and EMA approval for marketing, Canakinumab and secukinumab in several indications. In 2018, he joined Glenmark as an Executive VP of Clinical Development and within a month, he became the President and Chief Medical Officer, a position he held until joining Mesoblast in October 2019.While working in the pharmaceutical industry, Dr. Rahman maintained his educational and clinical activities. He was an adjunct Professor at University of Pennsylvania School of Medicine from 2002 to 2016 and a Clinical Professor at the Rutgers RWJ School of Medicine, Rheumatology Division, from 2016 to 2018. He has published more than 100 scientific papers in peer-reviewed journals.Scott A. Kelly, M.D., Chairman of the Board, Chief Medical Officer and Head of Business Development for CytoDyn, stated, “We are very pleased Dr. Rahman has joined our executive team. We expect his deep knowledge of immunology and successful regulatory experience to prove invaluable for patients and our Company.”Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We believe Dr. Rahman’s proven track record in our industry, coupled with his medical and research expertise will undoubtedly help accelerate many of our clinical and regulatory priorities. With the addition of Dr. Rahman, along with Dr. Scott Kelly, our CMO, and Dr. Nitya Ray, our CTO, we believe we are well-positioned to move CytoDyn into its next phase of development.”About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company’s questions concerning its recent Biologics License Application (“BLA”) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com. Forward-Looking Statements  This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CONTACTS Investors: Michael Mulholland Office: 360.980.8524, ext. 102 mmulholland@cytodyn.com

Investors need to pay close attention to Mesoblast (MESO) stock based on the movements in the options market lately.

Mesoblast Limited (MESO) +2% premarket says that the randomized controlled Phase 3 trial of remestemcel-L, an allogeneic mesenchymal stem cell product derived from bone marrow, in COVID-19 patients with moderate-to-severe acute respiratory distress

NEW YORK, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)))), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the randomized controlled Phase 3

FDA fails to approve Mesoblast Steroid Refractory Pediatric Graft vs. Host Disease Stem Cell Therapy after FDA advisory board voted 9-1 recommending approval.FDA expresses concerns about Mesoblast MSC manufacturing process in its decision to request another placebo-controlled clinical trial.Mesoblast reveals it can only produce about 500 doses per bone marrow donation.Tiny Cynata Therapeutics has the answer to MSC scalability - unlimited doses from a single donor.